API

Aspirin, Paracetamol, Caffeine.

Drug classification

Aspirin: Analgesics (nonsteroidal anti-inflammatory drug); Paracetamol: Analgesics (acetaminophen); Caffeine: Stimulants (xanthine derivative).

Dosage form

Tablet

API strength per dosage

Each Tablet contains Aspirin 400mg, Paracetamol…

Dose

Adults: 1-2 tablets every 4-6 hours as needed, not exceeding 8 tablets in 24 hours. Not recommended for children under 12 years. Caution advised in elderly and those with renal or hepatic impairment; lower doses may be necessary. Consult healthcare provider for specific adjustments.

Mechanism of action

Aspirin inhibits cyclooxygenase-1 and -2 (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, leading to decreased inflammation and pain. Paracetamol acts on the central nervous system, possibly inhibiting COX enzymes, reducing pain and fever. Caffeine blocks adenosine receptors, enhancing analgesia and increasing alertness.

Indications

Mild to moderate pain, headache, migraine, menstrual pain, toothache, muscle pain, fever, symptoms of cold and flu.

Side effects

Gastrointestinal bleeding, ulceration, renal impairment, hepatotoxicity, Reye's syndrome in children, allergic reactions, increased heart rate, insomnia, nervousness.

Pregnancy category

Category D

Precautions

Avoid in peptic ulcer disease, asthma, hepatic or renal impairment, pregnancy, breastfeeding; caution in hypertension, heart failure; risk of Reye's syndrome in children with viral infections; possible interactions with warfarin, methotrexate, other NSAIDs; monitor for signs of gastrointestinal bleeding, hepatotoxicity.

Contraindications

Hypersensitivity to ingredients, peptic ulcer, hemophilia, severe hepatic/renal impairment, third trimester of pregnancy, children under 12 years, Reye's syndrome, concurrent methotrexate use at high doses.